The problem of over-volunteering in early phase clinical trials
This article discusses important problem of early phase clinical trials – over-volunteering. The overlapping or dual enrollment of healthy volunteers is a potential high risk not only to study subjects, but also to commercial sponsors because it could cause the delay in advancement of promising drug...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | Russian |
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Izdatelstvo OKI
2018-07-01
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| Series: | Качественная клиническая практика |
| Subjects: | |
| Online Access: | https://www.clinvest.ru/jour/article/view/406 |
| _version_ | 1797262054020612096 |
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| author | S. B. Fitilev A. V. Vozzhaev I. I. Shkrebniova D. A. Kliuev |
| author_facet | S. B. Fitilev A. V. Vozzhaev I. I. Shkrebniova D. A. Kliuev |
| author_sort | S. B. Fitilev |
| collection | DOAJ |
| description | This article discusses important problem of early phase clinical trials – over-volunteering. The overlapping or dual enrollment of healthy volunteers is a potential high risk not only to study subjects, but also to commercial sponsors because it could cause the delay in advancement of promising drug candidates. The problem of over-volunteering is payed special attention by clinical research professionals in foreign countries. Guidelines for early phase clinical trials recommend implementation of different control and prevention measures of multiple enrollment. The most effective instrument to prevent over-volunteering is considered to be a central internet-based registry of healthy volunteers. Such registries operate in various countries and differ in structure, scope of information collected, types of funding and management. The general operating principles of such registries are described on the example of TOPS data base. TOPS is а special system to prevent over-volunteering that is used by UK phase 1 units. In conclusion, authors urge regulatory authorities and pharmaceutical companies to approach this problem closely because over-volunteering is already a burning issue in our country. It is essential to improve relevant regulatory framework and launch central registries of healthy subjects with regard to international experience. |
| first_indexed | 2024-04-24T23:51:00Z |
| format | Article |
| id | doaj.art-9e73dac866de46a2ac45714b562eab17 |
| institution | Directory Open Access Journal |
| issn | 2588-0519 2618-8473 |
| language | Russian |
| last_indexed | 2024-04-24T23:51:00Z |
| publishDate | 2018-07-01 |
| publisher | Izdatelstvo OKI |
| record_format | Article |
| series | Качественная клиническая практика |
| spelling | doaj.art-9e73dac866de46a2ac45714b562eab172024-03-14T18:09:07ZrusIzdatelstvo OKIКачественная клиническая практика2588-05192618-84732018-07-0102586310.24411/2588-0519-2018-10045411The problem of over-volunteering in early phase clinical trialsS. B. Fitilev0A. V. Vozzhaev1I. I. Shkrebniova2D. A. Kliuev3ФГАОУ ВО «Российский университет дружбы народов», Россия, г. МоскваФГАОУ ВО «Российский университет дружбы народов», Россия, г. МоскваФГАОУ ВО «Российский университет дружбы народов», Россия, г. МоскваФГАОУ ВО «Российский университет дружбы народов», Россия, г. МоскваThis article discusses important problem of early phase clinical trials – over-volunteering. The overlapping or dual enrollment of healthy volunteers is a potential high risk not only to study subjects, but also to commercial sponsors because it could cause the delay in advancement of promising drug candidates. The problem of over-volunteering is payed special attention by clinical research professionals in foreign countries. Guidelines for early phase clinical trials recommend implementation of different control and prevention measures of multiple enrollment. The most effective instrument to prevent over-volunteering is considered to be a central internet-based registry of healthy volunteers. Such registries operate in various countries and differ in structure, scope of information collected, types of funding and management. The general operating principles of such registries are described on the example of TOPS data base. TOPS is а special system to prevent over-volunteering that is used by UK phase 1 units. In conclusion, authors urge regulatory authorities and pharmaceutical companies to approach this problem closely because over-volunteering is already a burning issue in our country. It is essential to improve relevant regulatory framework and launch central registries of healthy subjects with regard to international experience.https://www.clinvest.ru/jour/article/view/406клинические исследования ранних фазздоровые добровольцыпрофессиональное волонтёрстворегистр добровольцев |
| spellingShingle | S. B. Fitilev A. V. Vozzhaev I. I. Shkrebniova D. A. Kliuev The problem of over-volunteering in early phase clinical trials Качественная клиническая практика клинические исследования ранних фаз здоровые добровольцы профессиональное волонтёрство регистр добровольцев |
| title | The problem of over-volunteering in early phase clinical trials |
| title_full | The problem of over-volunteering in early phase clinical trials |
| title_fullStr | The problem of over-volunteering in early phase clinical trials |
| title_full_unstemmed | The problem of over-volunteering in early phase clinical trials |
| title_short | The problem of over-volunteering in early phase clinical trials |
| title_sort | problem of over volunteering in early phase clinical trials |
| topic | клинические исследования ранних фаз здоровые добровольцы профессиональное волонтёрство регистр добровольцев |
| url | https://www.clinvest.ru/jour/article/view/406 |
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